FDA Medical Device Recalls (openFDA)
Hitachi Healthcare Americas Corporation: OASIS MRI System
- Recall number
- Z-2339-2021
- Recalling firm
- Hitachi Healthcare Americas Corporation
- Product
- OASIS MRI System
- Status
- Terminated
- Initiated
- 2021-07-29
- Posted
- not on file
- Terminated
- 2023-09-08
- Reason
- There was no label on the pad packaging or notification in the user manual that the table pads contained dry natural rubber which is required by the Code of Federal Regulations section 21CFR801.437.
- Root cause
- Vendor change control
- Action
- On July 29, 2021, the firm distributed Urgent Medical Device Safety Alert letters to affected customers. Customers were informed that the anti-skid area on the bottom of the table pads contain dry natural rubber. If a patient or user inadvertently comes into contact with the anti-skid material, it may cause allergic symptoms. If this occurs, immediately seek medical care for the user or patient. The firm does not require any additional action by the user at this time. The firm will begin including revised labels and user manuals with newly manufactured systems which contain the required notification of the presence of dry natural rubber in the anti-skid area of the pads. The firm will not be taking any additional action for already distributed product. For questions, comments, or concerns, please contact: Aaron Pierce Director, QA/RA 1959 Summit Commerce Park Twinsburg, OH 44087 Phone (330) 425-1313 x2934, Fax (330) 963-0749 Email aaron.pierce@fujifilm.com
- Quantity
- 472 (US); 10 (OUS) Total
- Distribution
- Worldwide distribution - US Nationwide and the countries of Mexico and Brazil.
- Lot, serial or model codes
- M001-M329, M951
- 510(k) numbers
- ["K202030"]
- PMA numbers
- not on file
- Product code
- LNH
- Firm FEI
- 1528028
- Firm city
- Twinsburg
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28